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Completed

NCT Number: NCT06538688

Orthodontic Extrusion of High Risk Impacted Mandibular Third Molar

The goal of this clinical trial is to investigate the usage of maxillary miniscrew and cross-arch elastics for the orthodontic traction of the impacted mandibular third molar in close proximity to the inferior alveolar nerve to decrease the chance of nerve injury

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Key information

Conditions

Inferior Alveolar Nerve Injuries Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Facial Nerve Diseases Facial Neuralgia Mandibular Nerve Injuries Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trauma, Nervous System Trigeminal Nerve Diseases Trigeminal Nerve Injuries Wounds and Injuries

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university, Alexandria, Egypt

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About this study

To investigate the traction of the impacted mandibular third molar away from the inferior alveolar nerve by using the orthodontic miniscrew in the maxillary bone and cross-arch elastic power chain as a temporary anchorage device before extraction to avoid injury of the nerve and neurosensory complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with impacted mandibular third molar in close proximity to the inferior alveolar nerve.
  • Cooperative patients free of chronic diseases which interfere with needed results (e.g.diseases affect the bone regeneration ).
  • Patients with good oral hygiene.

Exclusion criteria

  • patients with limitation in mouth opening.
  • patients with mental or physical disabilities.
  • Allergy to anaesthetic components or antibiotics.

Treatment and study plan

Orthodontic extrusion of the impacted mandibular third molar by using the maxillary miniscrew and cross arch elastic power chain as a temporary anchorage device before extraction

Procedure

Orthodontic extrusion of the impacted mandibular third molar of high-risk for nerve injury using maxillary TAD.

Other names: Using temporary anchorage device (TAD)in the maxillary bone for traction of the impacted tooth before extraction

Primary outcomes

  1. Radiographically

    Time frame: 6months

    By measuring the amount of extrusion of the impacted tooth gained in millimetres Using CBCT

Secondary outcomes

  1. Clinical neurosensory assessment

    Time frame: 6months

    By using pinprick test in which ;A sharp dental probe was applied to the skin over chin region, lip and mucosa in a quick pricking movement and pain perception of the patient was assessed. Each area was tested three times bilaterally.the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation.

  2. clinical brush stroke directional test

    Time frame: 6months

    using a micro brush tip which was moved in horizontal and/or vertical directions on the chin area ten times and asked the patient to reproduce the movements the scale ranged from 0-2, where 0= no sensation, 1= decreased sensation and 2= normal sensation.

  3. Clinical Two-point discrimination test

    Time frame: 6months

    By using probes of caliper device which were drawn across the skin at constant pressure and patient was asked whether one or two points were felt, the minimum separation distance was felt by the patient was termed two point discrimination threshold.scoring from 0-2 in which; 0=>15mm, 1=8-15, 2= <8 .

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of Orthodontic Extrusion of Impacted Mandibular Third Molar in Close Proximity to Inferior Alveolar Nerve Prior to Extraction ( a Clinical Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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